An open-label, single-center, non-controlled pilot clinical trial to assess the efficacy of weekly semaglutide in combination with regular counselling sessions to reduce craving and use of chemsex associated drugs (CoSem4Chemsex) study.
Phase 2 – studying effectiveness and dosage
Conditions:
Craving for and use of chemsex-related drugs
Sponsor: Institute Of Tropical Medicine
trial.available_in:
БГ
Overview
Trial status: Authorised
Self-reported use CADs, Self-reported use crystallized methamphetamine, Self-reported use cathinones, Self-reported use GHB/GBL, Craving for crystallized methamphetamine at baseline and end of treatment, Craving for cathinones at baseline and end of treatment, Craving for GHB/GBL at baseline and end of treatment, Craving for alcohol at baseline and end of treatment, Quality of life at baseline and end of treatment, Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS), The cumulative proportion of participants reporting grade 3 to 5 of each side effect listed in the SAFTEE form over the course of the study whilst receiving semaglutide
Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)
Description
Self-reported use CADs, Self-reported use crystallized methamphetamine, Self-reported use cathinones, Self-reported use GHB/GBL, Craving for crystallized methamphetamine at baseline and end of treatment, Craving for cathinones at baseline and end of treatment, Craving for GHB/GBL at baseline and end of treatment, Craving for alcohol at baseline and end of treatment, Quality of life at baseline and end of treatment, Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS), The cumulative proportion of participants reporting grade 3 to 5 of each side effect listed in the SAFTEE form over the course of the study whilst receiving semaglutide
Who can participate
Age group: 65+ years, 18-64 years
Gender: Male
Target enrollment: 22 participants
Interventions
Ozempic 0.25 mg solution for injection in pre-filled pen
Drug
Ozempic 0.5 mg solution for injection in pre-filled pen
Drug
Ozempic 1 mg solution for injection in pre-filled pen